Label: OMNI FRESH BY FACELA HAND SANITIZER- alcohol gel

  • NDC Code(s): 78587-000-01
  • Packager: Industrias Facela SA de CV
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 10, 2024

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  • Drug Facts

  • Active Ingredient:

    Ethyl Alcohol 75%

    Antiseptic

  • Uses:

    • Hand sanitizer to reduce microorganisms on the skin.
    • Use this product when soap and water are not available.
  • Warnings:

    • For external use only.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Flammable. This product contains ethyl alcohol. Keep away from source of ignition.
    • Discontinue use if irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Read the entire label before using this product.
    • Dispense 2 pumps of produc onto palm of hand and rub thoroughly over all surfaces of both hands until dry.
  • Inactive Ingredients:

    Water, Tetrahydroxypropyl Ethylenediamine, Carbomer, Fragrance

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    OMNI FRESH BY FACELA HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78587-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETOL (UNII: Q4R969U9FR)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78587-000-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/202012/31/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)07/01/202012/31/2023
    Labeler - Industrias Facela SA de CV (851249359)
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